Syneos Health is hiring a Regulatory Consultant (CMC/ EU Market Exp)

Syneos Health is looking for a Regulatory Consultant (CMC/ EU Market Exp) to join our team. This role specializes in authoring and managing regulatory submissions for post-approval product lifecycle maintenance and supporting client projects, with a focus on EU markets.

What You'll Do

• Independently author and review Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, and other lifecycle maintenance activities.
• Assess change control from quality/regulatory departments to determine regulatory impact and develop submission strategy.
• Conduct research on existing product data relative to global or regional regulatory requirements for gap analyses and product development plans.
• Contribute to or prepare administrative and technical components of regulatory agency submissions (e.g., IND, MAA, NDA).
• Prepare briefing packages for regulatory agency meetings or scientific advice and support agency interactions.
• Manage and operationalize day-to-day regulatory activities for assigned projects according to timelines, budget, and scope.
• Participate as regulatory support on multidisciplinary project teams to develop products throughout their lifecycle.
• Act as a subject matter expert to help team members with troubleshooting and present solutions to project problems.
• Prepare estimates for regulatory services as part of single or multiple service proposals.
• Support client meetings to discuss proposals, project status, and for business development activities.
• Ensure compliance with global regulatory requirements and company policies.
• Prepare training materials and share best practices in the regulatory area.
• Participate as regulatory support in internal or external project audits and internal cross-functional initiatives.
• Contribute to the creation/maintenance of SOPs and process documentation.
• Provide oversight to team members in the execution of their project responsibilities.
• Maintain individual training records and complete all required training.

What We're Looking For

• 5+ years total work experience.
• 4+ years relevant experience in Regulatory Affairs.
• Markets experience in EU (mandatory).
• MS, M.Pharm, or PhD degree in a science-related field or equivalent experience.
• Demonstrated experience in authoring and reviewing Module 3 CMC sections for post-approval variations and lifecycle activities.
• Demonstrated experience in contributing to the preparation of regulatory submissions (e.g., IND, NDA, MAA, CTD).
• Excellent interpersonal, written, and verbal communication skills.
• Excellent customer service skills, ability to work as a team member and independently.
• Good quality management skills.
• Advanced skills in Microsoft Office Applications.
• Ability to interact with staff from multiple departments and offices to establish project standards.
• Good initiative, adaptability, and pro-activity.
• Strong analytical skills and good attention to detail.
• Ability to work concurrently on projects with differing specific instructions.
• Fluent in speaking, writing, and reading English.

Nice to Have

• Markets experience in GCC (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, UAE) and MEA.
• Strong experience in handling Veeva RIMS and TrackWise along with other RIMS systems.

Technical Stack

• Microsoft Office Applications
• Veeva RIMS
• TrackWise

Team & Environment

You will participate on multidisciplinary project teams and provide oversight to team members.

Benefits & Compensation

• Career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.

Work Mode

This role operates in a global context.

Syneos Health is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.